MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00546600

Device Problems Material Protrusion/Extrusion (2979); Optical Problem (3001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the left hepatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, they were able to start the procedure with the spyscope ds functioning well.Halfway through the procedure, the device just stopped working and visualization was lost.They tried to restart the controller and reconnected the spyscope ds; however, it still did not work.Reportedly, it was also noticed that the working channel sleeve of the spyscope ds protruded.The procedure was completed with a second spyscope digital access and delivery catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable and good.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the left hepatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, they were able to start the procedure with the spyscope ds functioning well.Halfway through the procedure, the device just stopped working and visualization was lost.They tried to restart the controller and reconnected the spyscope ds; however, it still did not work.Reportedly, it was also noticed that the working channel sleeve of the spyscope ds protruded.The procedure was completed with a second spyscope digital access and delivery catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable and good.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: problem code 2979 captures the reportable event of working channel sleeve protrusion.Block h10: a visual assessment was performed.As received, the working channel sleeve (wcs) protruded.Maximum wcs protrusion was observed when the distal tip was articulated by turning the small and large knobs in the counterclockwise directions.An image assessment for visualization was performed.The reported complaint of loss of visualization was not confirmed because, upon plugging the device into the controller, it displayed a live, clear image.No issues were identified with the image.The device was fully articulated in all directions.A guidewire was inserted through the working channel port and passed through the working channel.A spybite was passed though the working channel.There were no issues identified with the image when these functional evaluations were performed.The handle was opened and it was found within specification.The distal tip was cut.The distal cap was removed.The catheter was cut open using the cutting fixture.The wcs was removed.Witness marks were noted on the pebax.The white areas along bond a appear to show evidence of adhesion.The investigation of similar devices revealed a manufacturing issue related to bond b.Manufacturing process improvements have been implemented to address this issue.The complaint was consistent with the reported event of working channel sleeve protrusion.Based on investigation results, the probable cause selected for the wcs protrusion issue is manufacturing deficiency, which indicates that problems were traced to the manufacturing process.A dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.The dhr review confirms that the accepted device met all manufacturing specifications.

• Brand Name: SPYSCOPE DS
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8619543
• MDR Text Key: 145372795
• Report Number: 3005099803-2019-02562
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: 08714729863236
• Combination Product (y/n): N
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 0022583096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1